Comparative Safety and Efficacy of Remdesivir Versus Remdesivir Plus Convalescent Plasma Therapy (CPT) and the Effect of Timing of Initiation of Remdesivir in COVID-19 Patients: An Observational Study From North East India.

ABSTRACT

Introduction As per the COVID-19 treatment guidelines of India, remdesivir and convalescent plasma therapy (CPT) are indicated in moderate and severe patients. In this study, we have evaluated the comparative safety and efficacy of remdesivir versus remdesivir CPT combination and effect of early versus late initiation of remdesivir. Materials and methods A hospital-based observational study was conducted among hospitalized moderate and severe COVID-19 patients treated with either remdesivir and/or CPT as per national guidelines. Response to therapy was evaluated in terms of mortality, mechanical ventilation requirement, ICU requirement, and safety. Results and observations A total of 95 moderate and severe COVID-19 patients on remdesivir (n=35) or remdesivir + CPT combination (n=60) were included. Both the remdesivir and remdesivir + CPT groups were comparable in terms of baseline characteristics, however, proportion of patients with baseline serum creatinine >1.5 was higher in the remdesivir group. No difference was seen between both the groups in terms of mortality, mechanical ventilation requirement, ICU requirement, and safety parameters in the overall moderate and severe COVID-19 populations and when each of these severity categories (moderate and severe) were analyzed separately. Early initiation (<9 days from symptom onset) of remdesivir was associated with better treatment outcome in terms of mortality and requirement of ICU. Post-therapy shortness of breath and LFTs (liver function tests) elevation was more in the late initiation of remdesivir group, which may be due to the lack of efficacy and subsequent disease progression or a direct effect of the drug. The beneficial effect of remdesivir was maintained even after adjustment for important prognostic factors and baseline imbalances (age, sex, disease severity, CPT use, and serum creatinine level). Conclusions Early initiation of remdesivir was associated with clinical benefit in terms of mortality and mechanical ventilation requirement. However, addition of convalescent plasma therapy as an additional therapeutic modality to remdesivir was not found to be beneficial.